This invention relates in general to garments for patients who rely on intrusive medical devices. In particular, the invention relates to garments suitable for the accommodation of medical devices such as central venous catheters, gastronomy tubes, ostomy bags, bile bags, medical monitors and other devices.
As medical technology advances, greater numbers of patients are living longer with critical health problems. For health conditions in which the body cannot perform essential functions such as eating, filtering bile, or eliminating waste, surgical procedures combined with external medical devices can be used to assist and facilitate those functions. Depending on the patient's condition, one or several devices may be required on either a temporary or permanent basis.
Many of the medical conditions that warrant the use of such devices occur in the very early stages of life. In the year 2002 alone, 480,812 births in the United States were classified as premature, meaning that birth occurred prior to 37 weeks gestation. A majority of the health problems encountered by premature infants are due to the immature development of the organ systems. When a child is born with an underdeveloped gastrointestinal system, oral feeding is not possible. In those cases, a gastronomy tube, otherwise referred to as a feeding tube or G-tube, is surgically implanted, with one end of the tube inserted into the stomach through an incision near the navel and the other end extending externally. Adequate nourishment, as well as medication, can be administered through the G-tube. Once the G-tube is surgically implanted it remains in place as long as it is required by the patient.
Premature infants are not the only patients that utilize G-tubes. Children born with cerebral palsy, muscular dystrophy, or urea cycle disorders may experience swallowing difficulties that necessitate the use of the device. For some patients the feeding tube may be in place only temporarily until the ability to swallow is learned or returns. Sadly, however, many patients cannot learn to swallow, so the G-tube must remain in the patient permanently.
Not all G-tube patients are children or adults suffering from conditions present at birth. Many adults find themselves confronted with the need for a feeding tube later in life due to an accident, illness or stroke. Regardless of patient age or required use duration, proper maintenance of the G-tube is critical to patient health. The G-tube and insertion site should be kept clean from leaking fluids or soiling so as to preclude infection. Furthermore the G-tube should be protected from accidental or intentional pulling, jerking, or dislodging.
A device that is structurally similar to the G-tube is the central venous catheter (CVC), otherwise known as a central line. Often used by cancer victims or other chronically ill patients, the CVC is a flexible tube surgically inserted into the patient so that one endpoint is in a large vein leading to the heart and the other endpoint extends out of the body through a small exit aperture in the chest area. The central line is designed to allow bi-directional fluid flow. When used as an input device, medications and fluids can be administered and blood products transfused. As an output device, the CVC can be used to withdraw blood samples, so as to eliminate the need for repeated puncturing of veins in other areas of the body such as the arms, hands or legs. The CVC and exit site should be kept clean and dry to prevent infection. As with the G-tube described above, the central line should not be pulled, tugged or dislodged. If the line is jerked out of position, not only may the patient experience considerable pain, but he may also be compelled to undergo a surgical procedure to reposition the catheter.
Another device surgically adapted to a patient is a billiary catheter, otherwise referred to as a T-tube. To prevent the harmful accumulation of bile in the liver of a patient whose bile ducts are blocked, a percutaneous billiary drainage procedure is performed in which a billiary catheter is inserted through the skin into the bile ducts. Bile then drains from the liver through the T-tube to an external storage pouch known as a bile bag. The T-tube insertion site should be kept clean and dry to prevent infection and the tubing and bag should be secured in a manner that protects against accidental dislodging of the T-tube or puncturing or detachment of the bile bag. Patients are advised to secure the bile bag to their legs or pin them to their clothes.
A further example of an intrusive medical device is the ostomy bag used by patients who have undergone either a colostomy or an ileostomy. These procedures are performed on patients with bowel infections, obstructions, inflammations or injuries, as well as those with Crohn's disease or cancer. A portion of the intestine is removed, and the bottom of the remaining intestine is surgically pulled out of the body via a stoma or opening in the abdominal wall. It is then turned down and sutured to the skin around the stoma. A drainage pouch or bag known as an ostomy bag is attached to the opening to accommodate the drainage of waste from the intestine. In many cases the ostomy bag is designed to adhere to the body around the stoma. There are also ostomy bags designed to accept fluid flow from the stoma through a catheter. Proper maintenance requires that the ostomy bag be changed as necessary, and the stoma site kept clean and dry to protect against bacterial infection. Furthermore, the ostomy bag should be secured to prevent dislodgment, as well as to protect against damage to the ostomy bag or detachment of the bag from the stoma.
A final example of a medical device that may be worn by a patient is a medical monitor, such as a cardiac monitor or blood oxygen content monitor. Sensors attached to particular sites on the patient provide status information that is transmitted electronically to a display unit. Because the electrical wiring associated with the sensors may be quite lengthy, care should be exercised to prevent tangling of the wires.
The list above is not intended to be exhaustive, but is instead merely illustrative of the diversity of devices on which a patient may depend. From the examples discussed, it is evident that patients with a variety of ailments and conditions require medical devices; and that medical devices vary greatly in size, weight, and appearance. Some patients may be sufficiently ill so as to be confined in a hospital or long-term care facility. Others may remain bedridden at home. Conversely, some patients may be well enough to lead active, normal lives. Regardless of the individual patient condition, the patient and his health care providers should protect the insertion sites and the devices, yet make the patient as comfortable as possible. Tubing extending from the body can be bothersome as well as vulnerable to pulling and twisting. Pouches containing drainage fluid can feel bulky and heavy and generally uncomfortable. In addition to the physical discomfort there is also the psychological anxiety that the pouch will be perceived by the general public, or even worse, that the pouch will become dislodged and detached.
In general, patients utilizing these devices wear conventional clothing appropriate for their individual conditions, i.e. a hospital gown, simple undergarments, pajamas, or street clothes. Hospital gowns may allow easy access to the devices by the patient and his health care providers but afford the patient little or no modesty, comfort or warmth. Rare is the patient who is not somewhat self-conscious visiting with guests while clothed only in a hospital gown. Conversely, street clothes afford the patient more privacy, but may make access to the devices difficult or cumbersome. The difficulty is compounded for patients in nursing homes who lack mobility or whose size makes movement difficult even with assistance.
Patients who have resumed a fairly normal lifestyle and who mingle with the general public may prefer to remain discrete regarding their condition. For many patients, as well as their families and caregivers, it is important for the patient to appear “normal” and not attract attention due to the presence of medical devices, especially those considered unsightly, such as ostomy bags, which can also be odorous. Since it can greatly affect psychological well-being, a semblance of normalcy can be a significant factor in a patient's health. However, when these patients dress according to societal norms, they often find their professional attire or conventional daywear uncomfortable or ill-suited for the devices that must accompany them at all times.
Whether hospital attire or personal clothing is worn, most garments do not provide support or security for the medical devices, rather they offer some degree of concealment. There is a need for garments suitable for male and female patients of all ages that are adapted to accommodate intrusive medical devices so as to provide modesty for the patient, security for the medical devices, and access to the patient and the devices by medical personnel and the patient.
There is a need for a garment that can accommodate a variety of medical devices, ranging from extended flexible tubing to relatively large drainage and storage pouches. Many patients with health problems find they require more than one type of medical device. In the year 2002, twelve percent of births in the United States were premature. Advances in medical technology allow the majority of premature infants to survive, however many will experience complications which will require the short-term or long-term use of intrusive medical devices. Premature infants with underdeveloped organ systems may require a G-tube as well as an ostomy bag and central line. Likewise, patients with chronic diseases such as colon cancer may require both a central line for chemotherapy and blood products, as well as an ostomy bag for waste elimination if a portion of the intestine is removed.
There is a further need for a garment adapted for medical devices that can be easily donned by patients of all ages. Because it is important to keep device sites clean and dry, when a patient's garment becomes either wet or soiled, it should be changed. Consequently, the clothing of an infant with intrusive medical devices may have to be changed several times a day. Infants need garments which can be put on or taken off with a minimum amount of effort by the caregiver and minimal discomfort to the infant. The easier the garment is to put on, the shorter the changing time and the lower the risk that the infant will pull, jerk, dislodge or detach the medical device. Likewise, there is a need for a garment which will accommodate a variety of medical devices but will not interfere with changing an infant's soiled diaper. Because infants require diaper changes at regular intervals, there is a need for a garment which facilitates frequent diaper changes without necessitating frequent rearrangement of the patient's medical devices.
Similarly, for older patients who are confined to a bed or a wheelchair, there is a need for a garment which will accommodate medical devices, but which can easily be changed if the garment is soiled. This is especially important for those patients whose size or disability makes it difficult for caregivers to lift or move the patients. In recognition of the fact that older adults often become incontinent, there is a need for an adult garment adapted for medical devices that does not impede the changing of adult underpads.
There is a need for a garment that can accommodate medical devices as well as provide easy access to the insertion sites as well as the devices themselves. The exit port for a central line, the insertion site for a G-tube or billiary catheter, and the stoma site resulting from a colostomy or ileostomy can become infected if not properly maintained. The sites should be kept clean and dry, and, as in the case of the central line site, the bandage should be changed at regular intervals as well as when the area becomes wet or soiled. There is a need for a garment which facilitates access to device sites so that their status can be checked and proper care provided.
There is a need for a garment suitable for the accommodation of medical devices that allows for an outward appearance of conformity with the general public, so that the patient's medical condition is not overtly obvious. The garment should provide security for the devices while discreetly concealing their presence and affording the patient a degree of normalcy in regard to attire and appearance.
Finally, there is a need for a garment suitable for the accommodation of medical devices that facilitates the care and maintenance of the device site. G-tube sites are prone to leakage, yet should be kept clean and dry. There is a need for a garment that provides a means for keeping the site areas dry so as to reduce the risk of infection. There is also a need for a garment that provides for the elimination or masking of unpleasant odors.
Several garments in the prior art have attempted to address these needs. U.S. Pat. No. 5,048,122 to Prieur discloses a garment for shielding lines connected to a patient. The Prieur garment is intended for patients with an embedded catheter. The garment has a close-fitting body with a pocket on the inside surface of the garment at the site of the implanted catheter in which the catheter may be stored. U.S. Pat. No. 5,142,702 to Piloian discloses an upper body ostomy garment. The Piloian garment is loose-fitting at the waist and has an interior pocket for holding an ostomy appliance. Finally, U.S. Pat. No. 6,477,710 to Ojoyeyi teaches a garment for concealing patient medical devices. The garment has one or more hidden pockets on the inside surface of the front of the garment for holding a medical appliance. When an appliance is deployed it is withdrawn from the pocket and pulled out through an opening to the exterior of the garment.
While adequate for their intended purposes, the cited prior art leaves several of the previously expressed needs unanswered. The pocket of the Prieur garment is well-suited for the storage of a central venous catheter; however, because the garment is tight-fitting so as to secure the catheter, the garment as a whole is not amenable to the storage of bodily fluid bags such as ostomy or bile bags. Similarly, the pocket of the Piloian garment suffices for holding an ostomy bag, but is unsatisfactory for housing a central line catheter due to the location of the pocket. The Ojoyeyi garment, while having multiple pockets in a variety of locations on the front of the garment so as to house multiple devices, is primarily suited for appliances such as catheters and medical monitors with tubing and wires that can be coiled for storage then straightened when extracted through an opening to the outside of the garment. Thus, none of the cited garments sufficiently addresses the need for a garment which accommodates and conceals multiple medical appliances of various types.
Furthermore, the prior art garments do not answer the need for a garment that is not only easily donned and removed, but is also appropriate for patients ages ranging from infant to geriatric. The Prieur and Ojoyeyi garments, worn by infants as sleepers, require arms to be extracted and the entire garment pulled down the patient and removed when any portion of the garment is soiled to the extent that a change of dress is warranted. The Piloian garment, worn as a shirt, separates in the front for removal. While somewhat easier to remove, the style is less suited for infant wear, requires that arms must be slipped through sleeves, and requires the entire garment to be taken off when any portion of it becomes soiled or wet.
The aforementioned prior art garments do not answer the need for a garment that provides easy access to device sites on infant patients. Neither of the garments suitable for infant wear provides easy access to device sites for quick inspection and care of the site. The Prieur garment holds a catheter in an interior pocket on the front of the garment, but the opening of the garment is located away from the pocket so as to discourage access to the device by the infant. The Ojoyeyi garment provides easy access to the devices themselves via apertures by which the device can be extracted, but the apertures do not provide a means by which the device site can be inspected.